Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000431022
Ethics application status
Approved
Date submitted
25/05/2010
Date registered
27/05/2010
Date last updated
12/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of native banana starch on body weight and insulin resistance.
Scientific title
Effects of native banana starch supplementation versus metformin treatment on body weight and insulin sensitivity in obese non-diabetic women.
Secondary ID [1] 251733 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 257343 0
Condition category
Condition code
Diet and Nutrition 257485 257485 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Forty obese women were selected and divided in two groups in a 2-arm parallel trial. Participants were randomly assigned to receive either 30 g of native banana starch (NBS) by day dissolved in 240 ml of water or metformin 850 mg/day. Each subject attended the laboratory on three occasions, once before any intervention, again following 4 weeks of intervention and the last at the end of the experimentation after 8 weeks of treatments. An oral glucose tolerance test (OGTT) was carried out before any intervention and after 8 weeks of experimentation. After 12 h fasting a 75g OGTT was performed according to the World Health Organization (WHO) criteria. Blood samples were taken at 0, 30, 60, 90 and 120 min after oral glucose for measuring glucose and insulin.
Intervention code [1] 256493 0
Prevention
Intervention code [2] 256494 0
Lifestyle
Intervention code [3] 256565 0
Treatment: Other
Comparator / control treatment
Active control group receives metformin tablets 850 mg once a day after breakfast during 8 weeks.
Control group
Active

Outcomes
Primary outcome [1] 258445 0
Body weight measured by a Tanita BF-350 body composition analyzer.
Timepoint [1] 258445 0
At the beginning of the intervention period (baseline) and after 4 and 8 weeks of intervention.
Primary outcome [2] 258446 0
Insulin resistance estimated according to the Homeostasis Model Assessment (HOMA).
Timepoint [2] 258446 0
At baseline and after 4 and 8 weeks of intervention
Secondary outcome [1] 264232 0
Glucose tolerance as evaluated by an oral glucose tolerance test (OGTT). After a 10-12-h overnight fast, a catheter is inserted into an antecubital vein for blood sampling. Baseline samples are obtained and a glucose drink (75 g) is administered. Glucose and insulin are determined at 0,30,60,90 and 120 min after oral glucose.
Timepoint [1] 264232 0
At baseline and after the intervention period (8 weeks).
Secondary outcome [2] 264233 0
Other metabolic responses as assessed through blood concentration changes of cholesterol, tryglycerides, Magnesium, aspartate amino transferase (AST)and alanin aminotransferase (ALT).
Timepoint [2] 264233 0
At baseline and after 4 and 8 weeks of intervention
Secondary outcome [3] 264234 0
Markers of nutritional status such as height, abdominal circumference and body fat percentage (measured by impedance).
Timepoint [3] 264234 0
At baseline and after 4 and 8 weeks of intervention

Eligibility
Key inclusion criteria
1. Female 2. Body Mass Index (BMI) >30 3.HOMA-Index > 2.5 4. Fast glycemia under 126 mg/dL 5. 2 h postprandial glycemia under 200 mg/dl 6. Have mantained stable weight during three months prior to experimentation 7. To be under the care of a health care provider from the Instituto Mexicano del Seguro Social (IMSS) 8. Available for the duration of the study.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Inability to give informed consent 2. kidney or liver disease, 3. Diabetes mellitus 4.On psychiatric treatments 5. Smoker or alcoholic 6. Pregnant or receiving medical or naturist treatment to reduce body weight 7. Receiving hormonal therapy.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants were recruited among the hospital workers, their relatives and people visiting interned patients. Subjects were randomly assigned to receive banana starch or metformin. Concealment by allocation schedule held independently by central administration staff.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization was achieved by the use of a computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/04/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 2624 0
Mexico
State/province [1] 2624 0
Tabasco

Funding & Sponsors
Funding source category [1] 256984 0
Government body
Name [1] 256984 0
Secretaria de Educacion Publica a traves del Programa de Mejoramiento del Profesorado (PROMEP)
Country [1] 256984 0
Mexico
Primary sponsor type
University
Name
Universidad Juarez Autonoma de Mexico
Address
Av Universidad S/N
Colonia Magisterial
Centro. Villahermosa, Tabasco
C.P. 86040
Country
Mexico
Secondary sponsor category [1] 256245 0
Hospital
Name [1] 256245 0
Hospital General de Zona 46
Address [1] 256245 0
Prolongacion de Av Universidad Km 2.5
Colonia Casa Blanca
Villahermosa, Tabasco Mexico. C.P. 86060
Country [1] 256245 0
Mexico

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259027 0
Comite Local de Investigacion en Salud (CLIS)
Ethics committee address [1] 259027 0
Hospital General de Zona 46
Instituto Mexicano del Seguro Social
Prolongacion de Av Universidad Km 2.5
Colonia Casa Blanca
Villahermosa, Tabasco Mexico. C.P. 86060
Ethics committee country [1] 259027 0
Mexico
Date submitted for ethics approval [1] 259027 0
Approval date [1] 259027 0
01/03/2008
Ethics approval number [1] 259027 0
CLIS-2701-2008-05

Summary
Brief summary
Subjects with obesity have an increased risk of type 2 diabetes and cardiovascular disease. The key mechanism unifying obesity and diabetes is insulin resistance. Lifestyle changes have been recognised to be fundamental to prevent diabetes and cardiovascular disease among obese people. In a previous investigation we have demonstrated that native banana starch (NBS) supplementation reduces body weight and insulin resistance in a group of obese diabetics. In the present study our aim is to investigate the effects of NBS when compared to metformin on a group of obese women at a high risk of chronic diseases. Metformin is known to possess an important insulin-sensitizing antidiabetic action.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31147 0
Address 31147 0
Country 31147 0
Phone 31147 0
Fax 31147 0
Email 31147 0
Contact person for public queries
Name 14394 0
Dr Jorge Luis Ble Castillo
Address 14394 0
Centro de Investigacion
Division Academica de Ciencias de la Salud
Universidad Juarez Autonoma de Tabasco
Av Gregorio Mendez 2838-A
Colonia Tamulte
Villahermosa, Tabasco, Mexico
C.P. 86150
Country 14394 0
Mexico
Phone 14394 0
+52 993 3581500 ext 6313
Fax 14394 0
+52 993 3511132
Email 14394 0
[email protected]
Contact person for scientific queries
Name 5322 0
Dr Jorge Luis Ble Castillo
Address 5322 0
Centro de Investigacion
Division Academica de Ciencias de la Salud
Universidad Juarez Autonoma de Tabasco
Av Gregorio Mendez 2838-A
Colonia Tamulte
Villahermosa, Tabasco, Mexico
C.P. 86150
Country 5322 0
Mexico
Phone 5322 0
+52 993 3581500 ext 6313
Fax 5322 0
+52 993 3511132
Email 5322 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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